Evaluation of the Organ-Protective Effects of Remote Ischemic Preconditioning in Patients Undergoing Surgery for Acute Type A Aortic Dissection: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of this clinical trial is to learn if a technique called remote ischemic preconditioning (RIPC) helps protect organs during emergency surgery for acute type A aortic dissection (ATAAD). The main questions it aims to answer are: Does RIPC reduce the risk of major complications after surgery, such as heart, brain, or kidney problems? Is RIPC safe to use during emergency ATAAD surgery? Researchers will compare the RIPC group to a control group (who will receive a placebo) to see if RIPC can reduce complications after surgery. Participants will: Receive either RIPC or a sham intervention during their surgery. Be monitored for up to 30 days after surgery for complications. Have follow-up visits at 3 months, 1 year, and then yearly for up to 5 years to track their recovery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years, with no restriction on sex;
• Diagnosis of acute Type A aortic dissection requiring emergency surgery (symptom onset \<14 days);
• Ability to understand the study objectives, voluntary provision of written informed consent by the patient or a legally authorized representative, and willingness to comply with follow-up.
Locations
Other Locations
China
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Xiamen Cardiovascular Hospital, Xiamen University
NOT_YET_RECRUITING
Xiamen
Contact Information
Primary
Liang-wan Chen, M.D Ph.D
chenliangwan@fjmu.edu.cn
+8613358255333
Backup
Xin-fan Lin, M.D
lxf1885@163.com
+8617850019550
Time Frame
Start Date:2026-01-05
Estimated Completion Date:2032-12-31
Participants
Target number of participants:1296
Treatments
Experimental: RIPC Intervention Group
Participants randomized to this group will receive remote ischemic preconditioning (RIPC). After induction of general anesthesia, RIPC will be applied to the upper arm and thigh on the non-arterial cannulation side. The procedure consists of four alternating ischemia-reperfusion cycles, each cycle comprising 5 minutes of cuff inflation (at 200 mmHg, or systolic blood pressure +15 mmHg if systolic blood pressure exceeds 185 mmHg), followed by 5 minutes of cuff deflation for reperfusion. The inflation process alternates, starting with the upper arm. The thigh cuff inflation will begin only after the first upper arm inflation cycle is completed, and this process will repeat in alternating cycles.
Sham_comparator: Control Group
Participants randomized to this group will receive a sham RIPC procedure. The same cuff placement and timing as the experimental group are used, but the cuff is inflated to only 20 mmHg for 5 minutes followed by 5 minutes of deflation, simulating the RIPC procedure without inducing ischemia.